Product Category Rules

“Programme operators should facilitate harmonization when developing PCR for a product category by considering the adoption of readily available PCR documents in the same product category and in the appropriate market area. However, there may be valid reasons for developing PCR documents that have different content from those that are already existing. The justification for differing from existing PCR shall be based on the content of existing PCR documents; and shall not, for example, be based on the origin of any particular PCR.

The efforts undertaken to achieve harmonization, the outcome and the explanations for not using readily available PCR shall be reported in the PCR document.”